In this open-label multicenter trial patients with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (docetaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide) concurrent with either SC Herceptin or IV Herceptin. After surgery patients will receive a further 10 cycles of Herceptin SC or IV as per randomization to complete 1 year of treatment. After the end of study treatment patients will be followed for safety and efficacy for at least 5 years, or until disease recurrence, whichever is earlier.

At least 1 measurable lesion in breast or lymph nodes according to RECIST v1.0 criteria, except for inflammatory carcinoma

Baseline LVEF >/= 55%

Exclusion Criteria:

History of any prior (ipsi- and/or contralateral) invasive breast carcinoma

Past or current history of malignant neoplasms, except for curatively treated basal and squamous cell carcinoma of the skin and in situ carcinoma of the cervix

Metastatic disease

Any prior therapy with anthracyclines

Prior anti-HER2 therapy or biologic or immunotherapy

Serious cardiac illness

Pregnant or lactating women

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950300